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Supply Side West 2009Energy Shots and Beverages: Growth, Innovation, Safety and
Regulation Legal and Regulatory Issues Affecting Energy Shots and
Beverages
Anthony L. Young
Kleinfeld, Kaplan & Becker LLP
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ENERGY BEVERAGE WEBSITE
• http://www.screamingenergy.com/
• More than you ever would want to know, but . . .
• Products that stretch the imagination of even the most jaded marketeer
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ENERGY BEVERAGE WEBSITE OCTOBER ENTRY
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Food or Dietary Supplement
• First Issue – What is it• Marketer picks the category - food or
dietary supplement• Nutritional Facts for food • Supplement Facts for dietary
supplements• Customers and retailers no longer
make a distinction• 7-11 would know the difference?
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Energy Shots and Beverages Focus on Particular Consumer
Needs• Energy
• Stimulation
• Alertness
• Focus
• Attention
• Stay awake
• And more “energy”
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Energy Shot Ingredients Besides SUGAR
• Caffeine, guarana and other caffeine source ingredients
• Taurine
• L-carnitine
• B vitamins
• Ginseng
• Amino acids
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Taurine
• Not technically an amino acid but referred to as one
• Supports neurological development and helps regulate the level of water and mineral salts in the blood
• Thought to have antioxidant properties• Some studies suggest taurine
supplementation may improve athletic performance
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B vitamins
• Important in cell metabolism
• Help convert food to energy
• Well known for energy support
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L-carnitine
• Synthesized in the liver and kidneys from amino acids and stored in muscle
• Helps the body turn fat into energy
• May be difficult to formulate so that it survives processing
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Ginseng and Ginkgo• Ginseng reported to increase the body’s
resistance to stress (adaptogen)
• Ginseng is traditionally used as a stimulant: thought to improve mental and physical performance
• Ginkgo to enhance blood circulation
• Ginkgo to enhance memory
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Glucuronolactone
• Carbohydrate
• Produced by the metabolism of glucose in the liver
• Structural component of most connective tissues
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Milk Thistle Extract and Acai• Milk Thistle historically used to treat liver
disease and to protect the liver against toxins
• Acai has measured antioxidant properties (contains anthocyanins and flavonoids)
•
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ENERGY and Shot Claims
• Energy
• Feel it in minutes
• Energy for a specific period
• Energy for a specific purpose
• More energy
• Claims are supported by energy related professional sports endorsements that reinforce ENERGY
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ENERGY and Shot Claims
• Some performance enhancment claims
• Red Bull, the 800 lb Gorilla in the marketplace, appears to make some of the more aggressive and specific claims
• All In is one to take in Vegas - it has an interesting poker tie-in, instead of the athlete ties of most energy beverages
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RED BULL Claims
– Increases performance– Increases concentration and reaction speed– Improves vigilance– Improves emotional status– Stimulates metabolism – Vitalizes body and mind – Developed for times of increased mental
and physical exertion
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Other Energy Drink Claims
• twice the buzz of a regular energy drink
• ideal for persons who need a boost but aren’t afforded the most timely restroom breaks
• scientifically formulated to provide an incredible energy boost for those who lead active and exhausting lifestyles
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ALL IN Claims
• All In delivers the ideal premium energy drink to the fast moving world of poker.
• All In is a premium product…without sugar, carbs, or excess calories.
• All in uses herbs, vitamins and amino acids and provides a smooth, sustained sharpening of focus and pure energy every poker player needs.
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Other Energy Shot Products
• Dr. Chao - Herbal Lady Drink (PMS)
• Dr. Chao - Herbal Adult Drink
• Dr. Chao – Herbal 21 Drink
• Dr. Chao – Herbal Stress Reliever Drink
• Note for Blumenthal – no Herbal Guy drink
• And no Herbal Lawyer Up drink either18
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Herbal Lady Drink
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Energy Shots and Beverages Labeled as Foods
• Nutrition Facts Box is limited to nutrients – no place to display functional non-nutrients – so taurine and guarana cannot be included.
• On the Information Panel, non nutrient ingredients must be included only in the ingredients declaration for the product.
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FDA Regulations Limit Health and Nutrient Content Claims for Foods
and Dietary Supplements
• Nutrient content claim regulations limit claims about the presence of ingredients to FDA - recognized nutrients.
• To tout the presence of ingredients, the actual amount per serving must be stated.
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First Amendment and FDA
• In 2002 FDA asked for comment on those FDA claim rules believed to infringe on truthful and not misleading commercial speech.
• Nutrient content claim regulations were identified as First Amendment suspect – but this proceeding never got off the ground, and now never will.
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Nutritive Value - Food
• FDA defines nutritive value as value in sustaining human existence by such processes as promoting growth, replacing lost nutrients, or providing energy
• Physiological effect that provides a benefit through growth or health improvement probably meets the definition
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Claims for Foods More Restrictive than Dietary Supplements
• Health Claims – F and DS• Qualified Health Claims – F and DS• Structure Function Claims for foods
based on nutritive value effects or taste or aroma of the food – F
• Structure Function Claims for dietary ingredients based on demonstrated effect on structure or function of the body – DS
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Dietary Supplements in Conventional Food Form
• May be in conventional food form but must be represented as supplement and not conventional food
• May not be represented as a meal or meal replacement or snack
• May not be linked to a meal or conventional food form
• Labels, labeling and advertising must stay out of food arena
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New Ingredients for Energy Shots
• New ingredients or novel forms of old ingredients must meet regulatory requirements for foods or supplements
• New or novel food ingredients must be GRAS or food additive approved
• Dietary ingredients must be old ingredients or lawfully marketed new dietary ingredients
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Ingredients In Energy Drinks
• Surprised to see that there is little exotica in the ingredients
• Marketeers here appear to be looking for marketing niches based on endorsements, affiliations and packaging
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GRAS Substances for Food Energy Shots
• § 402(a)(2)(C): adulterated if it contains an “unsafe” food additive
• § 409: “unsafe” food additive is one not covered by an FDA regulation, OR
• the substance is GRAS through common knowledge throughout the scientific community
• Reasonable certainty that the substance is not harmful under the specific intended conditions of use – (reasonable certainty of no harm)
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Conditions of Use
• GRAS notifications to FDA must list the foods for which the ingredient is intended
• 21 CFR Sec. 170.3• Must describe and list proposed amounts
for the food category • Many food ingredients are NOT GRAS for
all uses
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GRAS Self-Affirmation
• Scientific Procedures– Generally available and accepted
scientific data Ordinarily published Corroborated by unpublished data
– Normally reviewed by expert panel– OR
• Common use in food prior to 1958• NO FDA REVIEW LEGALLY REQUIRED
FOR EITHER CATEGORY
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GRAS Self-Affirmation
• GRAS self-affirmation is a predicate for the use of an ingredient in food
• Panel of Experts review and conclusion is important to customers
• If FDA finds the ingredient and questions its use, the GRAS Self-Affirmation package provides a defensive conversation piece
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GRAS Self-Affirmation
• Largest ingredient customers (Coca-Cola, Pepsi) may not accept GRAS self-affirmation for an ingredient
• If FDA disagrees with the use of a self-affirmed ingredient in food they may advise customer that their products may be adulterated.
• FDA may make products containing the ingredient subject to seizure or injunction
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GRAS NOTIFICATION TO FDA
• Since mid-1997 GRAS Notification may voluntarily be submitted to FDA– Proposed Rule 62 FR 18938 4/17/97– If successful, results in a “No-Question”
letter– Replaces the old GRAS-affirmation
process– Replaces a regulatory process that was
too long – required too much FDA buy-in
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FDA GRAS NOTIFICATION WEBSITE
• FDA provides guidance to those considering GRAS notification
• FDA provides chronology of GRAS notifications and responses
• FDA response letters provide good guidance on data requirements
• FDA provides guidance on estimating total dietary intake of the substance
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Successful GRAS Notifications
• Pre-submission meeting with FDA with Expert Panel Report as meeting baseline
• Listening carefully to what FDA says pre-submission
• Some published data and information• Data and information package presents
quality relevant data • GRAS notification is written by someone
schooled in FDA data requirements and FDA lines of inquiry
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Successful GRAS Notifications
• Panel of Experts ARE “qualified by training and experience to evaluate the safety of the substance under the conditions of use” proposed
• The proposed conditions of use are not controversial for the ingredient
• Panel of Experts addresses all relevant and expected issues including any raised by FDA pre-submission
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FDA Informal Responses
• FDA GRAS Notification review staff is experienced and knowledgeable
• Review staff is not restrained from asking questions to clarify the submission
• Review staff will advise notifier if the notification is going to receive an unfavorable response
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Old Dietary Ingredients
• On the market prior to October 15, 1994
• Must be one of the defined dietary supplement ingredient catagories
• Must not have been a new drug ingredient – ephedrine HCl example
• And probably not on the market as a drug
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New Dietary Ingredients
• Developed since October 15, 1994
• NDI premarket notification required unless the ingredient is present in the food supply and is used in a form in which the food has not been chemically altered
• If you claim it is new, different or never before available, you need to respect the NDI requirements
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Basic Safety Premise
• Reasonable expectation of safety when used or consumed as directed
• Don’t test new product ingredients on the customer
• How would you like to testify in court that “you thought it was safe” but had never sought to substantiate it.
• Have a reasonable basis that ingredient combinations are safe.
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New Sheriff in Town
• With the changed Administration, expect more concern around safety of foods and dietary supplements
• The National Nanny is back in residence, we will be told what is good for us
• Expect some focus on large amounts of SUGAR and CAFFEINE in products.
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Energy Shots are “Functional Foods”
• Industry has said that no new regulatory definition or distinct regulatory approach is necessary for the evaluation of the safety of ingredients added to ``functional foods'‘.
• More use of labeling and restrictions on use was suggested for GRAS review of functional ingredients.
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Energy Drinks Under Scrutiny
• 12 year old reports results of study conducted to see if energy drinks like “Monster” delivered as intended. Brendan D. O’Neil – future MD
• Caffeinated “Monster” against decaffeinated Sprite
• “Monster” as compared with soday had no significant effect on exercise performance.
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Energy Drink Study Author
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Energy Drink Safety
• These products are being sold to people who want a faster lifestyle, the issue of the safety of caffeine, as well as other ingredients will be raised about this category.
• Similar to the sports supplement model, the marketing is to a population that makes itself vulnerable.
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Caffeine
• Medline Plus says: It is recommended that pregnant women consume less than 300 mg of caffeine a day.
• Caffeine passes into breast milk in small amounts and may build up in the nursing baby.
• FFDCA Section 201(n) material information for Moms – why NOT require added caffeine to be labeled?
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Caffeine
• Major marketers of caffeine containing beverages include the amount of caffeine on their product labels.
• Some energy shot product contain caffeine amount labeling and a caution regarding use by pregnant women.
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Additional Energy Drink Consideration
• Took a boat tour of the Chicago River
• First drink on the bar menu was Red Bull and Vodka
• All foods should be compatible with all foods – so mixing into cocktails is no surprise
• But formulators should take the liquor mixing into consideration
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WHERE’S THE ACTION?
• CALIF AG lawsuit against Kellogg's for Immunity Claim on cereals – no surgical mask for Tony the Tiger – Pvt lawsuits follow
• Consumer class action against Danone and over $30 million (note $ not Euros)
• Lawsuits over “natural” and the like
• Success has benefits, and a price
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FDA Functional Food HearingNovember 2006
• There was no support for a requirement that companies that market ingredients for addition to ``functional foods'' notify FDA prior to introducing the ingredients into interstate commerce.
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FDA Functional Food Hearing
• There appeared to be agreement that data and information appropriate to demonstrate that ingredients added to conventional foods being marketed as ``functional foods'' meet the present safety standard of ``reasonable certainty of no harm'‘ and achieve GRAS status.
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FDA Functional Food Hearing
• Commentators did not support a premarket notification process for presentation of the scientific evidence supporting structure/function claims for ``functional foods'' and ingredients, as recommended by IFT.
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FDA Functional Food Hearing
• There was agreement that conventional foods being marketed as ``functional foods'' could be adequately addressed through the current regulations for food additives, GRAS substances, and labeling claims.
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Glossary of Terms
• Food – a food for man providing taste, aroma or nutritive value, including chewing gum.
• Dietary Supplement – a product for ingestion, other than tobacco, intended to supplement the diet that contains a vitamin, mineral, herb/botanical, amino acid, dietary substance, or concentrate, metabolite, constituent or extract, or a combination of those ingredients.
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GRAS
• GRAS – applies to food ingredients, GRAS means Generally Recognized as Safe for use in food by experts qualified by training and experience to evaluate the safety of such ingredients
• GRAS Self-Affirmation – a safety review by experts for use by a company marketing or using a food ingredient
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GRAS Basis
• Common use in food prior to 1958 when the Food Additive Amendments were passed shows safety
• Scientific procedures which can mean a variety of scientific information ranging from in vitro tests, animal studies, to human clinical studies, some published, that show safety
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Dietary Ingredient
• Vitamin, mineral, herb/botanical, amino acid, dietary substance, or concentrate, metabolite, constituent or extract
• If a dietary substance, FDA position is that it must be an ingredient consumed in the diet